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Trial record 79 of 344 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Entecavir to TAF Switch

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ClinicalTrials.gov Identifier: NCT03489239
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Tenofovir Alafenamide Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : November 16, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Arm
SingleArm: TAF 25 mg
Drug: Tenofovir Alafenamide
subjects switching from Entecavir to single arm TAF 25mg
Other Name: TAF



Primary Outcome Measures :
  1. Results of viral Hepatitis B DNA to be <20 IU/mL [ Time Frame: 48 weeks ]
    The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.


Secondary Outcome Measures :
  1. Complete viral suppression at study completion [ Time Frame: 96 Weeks ]
    The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96.

  2. Positive eGFR changes at study completion compared to Baseline visit [ Time Frame: 96 weeks ]
    Change in eGFR from baseline to Week 96

  3. Improved Bone Mass Density at study completion [ Time Frame: 96 weeks ]
    % change from baseline in BMD at the hip and lumbar spine at Week 96.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
  • Maintained on Entecavir for a minimum of 48 weeks
  • Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
  • Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.

Exclusion Criteria:

  • Subjects with known poor or non-compliance
  • Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
  • Pregnant women and those who wish to become pregnant during the course of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489239


Contacts
Contact: Hie-Won Hann, MD 215-955-5806 hie-won.hann@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Hie-Won Hann, MD    215-955-5806    hie-won.hann@jefferson.edu   
Contact: Grace Park, BA    215-955-5806    grace.park@jefferson.edu   
Principal Investigator: Hie-Won Hann, MD         
Sponsors and Collaborators
Thomas Jefferson University
Gilead Sciences

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03489239     History of Changes
Other Study ID Numbers: 11729
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Tenofovir
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents